Spai srl is a consulting, compliance and validation company based in Bologna. Founded in 1998, Spai srl has more than twenty years of experience in packaging and pharma industry, with specific regard to validation, assisted maintenance, managing of technical information, consulting and training. Already working with pharma suppliers, Spai srl is now addressing directly the pharma industry, to propose a new approach to pharmaceutical validation. To understand it, it’s useful to start with a question: which is the difference between testing and validation? This is a crucial question in pharmaceutical industry, because the concepts behind these two words are often confused.
Fabio Farneti, owner of Spai srl, faces the question, explaining the difference between these two activities.
The testing activity: who does it, why, and what happens next
Farneti starts with the concept of testing, usually divided in two kinds:
- FAT: Factory Acceptance Test, performed before the equipment arrives to the client;
- SAT: Site Acceptance Test, performed after installation.
Testing must be performed by the equipment’s supplier and its purpose is to verify if the product is compliant with the project specifications and with the client’s requests.
In the pharmaceutical industry, the testing activity is part of the Quality System. For this reason, it must be regulated by procedures and is subject to data integrity. Thus, it is necessary to record the testing’s characteristics: the tests performed, the name of the operator in charge, the results obtained and the date in which the testing took place.
Then, if the result is positive, the equipment is commissioned to the client, according to an agreement between parts. On the other hand, if the testing ends with a negative result, the supplier has to recall the equipment or fix the highlighted problem.
The validation process and its follow up
Farneti goes on explaining that the validation process is instead very different. First of all, it must be performed by the client as user of the equipment. The aim of the validation is to confirm that the process carried out with the equipment is safe for the patients that will take that medicine and that it complies with the requirements of data integrity. This is true no matter which step of the medicine life cycle is performed with the equipment: a productive step, a packaging one or a distributive one.
Part of a validation process is also the equipment qualification, that in the pharmaceutical industry is part of the Quality System. There are three kinds of qualification:
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
The IQ usually takes place before the equipment is switched on, while the OQ aims to make sure that it works properly. Finally, the PQ is performed to verify the equipment during the real process for every kind of company’s product.
The final purpose of validation is thus to ascertain the compliance of the product realized with the equipment. So, after a good qualification, the company obtains the production or packaging authorization by the competent regulatory agency.
However, every time a critical part of the equipment is changed or modified, the user has to perform a new validation for that part. In this way it is possible to verify that the process has not been negatively impacted. This activity, named “change control“, is mandatory to avoid the withdrawal of the authorization previously released by the regulatory agency.
The difference between testing and validation
Testing and validation are very different operations for purpose, effect and follow up, Farneti states. It is possible to get confused because some steps in validation and testing processes are similar, but it is important to keep in mind the difference.
A validation process is complex and rigorous, while a testing can be agreed and modulated between parts. Although more rigid, the validation process can be performed only on the parts of the equipment involved in the final quality of the product, rather than on the whole. Because of its consequences, this difference between testing and validating is crucial for the company.
If we consider every part involved in the testing as critical, indeed, we are considering testing and validation as the same, with a consequent chain of losses:
- loss of time to prepare more documents;
- loss of productivity because of the increased validation activity;
- loss of money due to the revalidation every time a non-critical part of the equipment is changed or modified.
Farneti tries then to shed some light on those bad habits, finding for them different reasons. First of all, sometimes companies are slow in accepting the historical evolution of the validation process. The changes happened over time might have not been already integrated in the procedures, so that the company remains tied to an old way of performing a validation. Another possibility is the easiness of the companies to surrender to the regulatory requests without trying to explain their own ideas: surely a simple way, but not always the right one. Finally, the companies may not have enough resources to perform the validation on their own. So they ask for help their suppliers, that sometimes don’t understand correctly the company’s needs.
